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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC
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BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC Back to Search Results
Model Number M00522612
Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip opened; however, the clip would not close properly nor deploy.The procedure was completed with another resolution clip device.It was also noted that there was an attempt to completely remove the sheath from the device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block h6: conclusion code 4316 is being used to capture that the event is no longer reportable.Additional information: b5, e1 (initial reporter phone), h6 (device code), h10 (additional mfr narrative).
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip opened; however, the clip would not close properly nor deploy.The procedure was completed with another resolution clip device.It was also noted that there was an attempt to completely remove the sheath from the device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6), 2020*** it was reported that the clip would not close; thus, the clip was not attempted to be released from the catheter.
 
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Brand Name
RESOLUTION CLIP CLIPPING DEVICE
Type of Device
CLIP, HEMOSTATIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10476032
MDR Text Key205496023
Report Number3005099803-2020-03641
Device Sequence Number1
Product Code MCH
UDI-Device Identifier08714729504818
UDI-Public08714729504818
Combination Product (y/n)N
PMA/PMN Number
K040148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/27/2022
Device Model NumberM00522612
Device Catalogue Number2261
Device Lot Number0024243636
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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